For the case of pluripotent stem cells, since the stem cells offer the potential for an unlimited source for cell therapy products, they might behave like tumor cells or have the possibility for unintended differentiated cells or transformation of cells similar to malignant tumors. We hereafter refer it as tumorigenicity. Because of the complex nature of the cell therapies and the lack of a globally accepted consensus on the strategy for tumorigenicity evaluation, scientists have proposed different studies for the risk assessment in each cell therapy product. In general, therapeutic products need to be qualified using available technologies, which ideally should be fully validated. In such circumstances, the developers of cell therapy products may have conducted various tumorigenicity tests and consulted with regulators in respective countries.
Conventionally, public-known method of tumorigenicity test for cell therapy are soft agar culture method in vitro or by use of a high-sensitive immunodeficient mouse (NOG mouse) in vivo.
Conventionally, public-known method of tumorigenicity test for cell therapy are soft agar culture method in vitro or by use of a high-sensitive immunodeficient mouse (NOG mouse) in vivo.